Allopregnanolone for Traumatic Brain Injury (TBI)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Durham VA Medical Center, Durham, NC, Durham, NC
Traumatic Brain Injury (TBI)+2 More
Allopregnanolone - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a chemical found in the body may help improve depression and pain symptoms in individuals who have a history of mild traumatic brain injury.

See full description

Eligible Conditions

  • Traumatic Brain Injury (TBI)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Allopregnanolone will improve 2 primary outcomes and 1 secondary outcome in patients with Traumatic Brain Injury (TBI). Measurement will happen over the course of 6 hours, 24 hours, 7 days, and 14 days.

Day 14
Brief Pain Inventory, Short Form (BPI-SF) Change
Hamilton-Depression Inventory (HAM-D) Change
Short Form Health Survey (SF-36) Change

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

Placebo
1 of 3
ALLO 50 nM
1 of 3
ALLO 150 nM
1 of 3
Experimental Treatment

This trial requires 132 total participants across 3 different treatment groups

This trial involves 3 different treatments. Allopregnanolone is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Placebo
Drug
ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
ALLO 50 nM
Drug
ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
ALLO 150 nM
Drug
ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brexanolone
FDA approved
Placebo
1995
Completed Phase 3
~2810

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 hours, 24 hours, 7 days, and 14 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 hours, 24 hours, 7 days, and 14 days for reporting.

Closest Location

Durham VA Medical Center, Durham, NC - Durham, NC

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. You must have received 1 prior treatment for Traumatic Brain Injury (TBI) or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
confusion or disorientation
loss of consciousness for 30 minutes or less
post-traumatic amnesia for less than 24 hours
and/or other transient neurological abnormalities such as focal signs, and intracranial lesion not requiring surgery
Ability to participate fully in the informed consent process
HAM-D score 14 (HAM-D range for moderate depression=14-18)
History of mild TBI since 2001 and service in the U.S. Military since 9/11/01 (OEF/OIF/OND era)
21-62 years of age, any ethnic group, either sex
Participants will meet DSM-5 criteria for major depressive disorder (by SCID)
The presence of psychotic features will be exclusionary

Patient Q&A Section

What are the signs of brain injuries?

"Seizures, cranial nerve deficits, loss of consciousness, and a rapid return to consciousness all occur commonly with brain injuries. All of these can cause complications for the patient." - Anonymous Online Contributor

Unverified Answer

What causes brain injuries?

"The brain is the most highly protected organ, which can withstand a large range of damage from traumatic brain injuries. Although the mechanism of injury is not yet fully understood, brain injuries can be minimized by limiting the magnitude of trauma and increasing the likelihood of secondary prevention. The pathomechanism of head-induced injuries is largely unknown, but some mechanisms are known. It is not yet known whether a trauma is necessary for development of brain injuries." - Anonymous Online Contributor

Unverified Answer

What is brain injuries?

"Brain injuries are a broad term covering a wide range of brain diseases. The majority of brain injuries are caused by motor vehicle accidents, falls, or penetrating trauma (shrapnel or bullets). The majority of severe brain injury is related to head injury; many of them are associated with significant long term disability and functional impairment, which may manifest in changes in personality, learning or other aspects of cognition. The prognosis varies depending upon severity of the injury: head injury, falls, motor vehicle accidents and subdural haematomas are more likely to result in death or serious disability, compared to the prognosis after penetrating trauma." - Anonymous Online Contributor

Unverified Answer

What are common treatments for brain injuries?

"The common treatments for brain injury patients are primarily medical. As most brain injuries are non-brain related, physicians can provide a multi-faceted approach to the treatment of brain injuries." - Anonymous Online Contributor

Unverified Answer

Can brain injuries be cured?

"There is no way around these injuries that cannot be treated, and the outcome will depend on the extent and type of brain injury. Patients are best served if damage is limited to the focal region of injury, and the goal should be re-establishing normal function." - Anonymous Online Contributor

Unverified Answer

How many people get brain injuries a year in the United States?

"Brain injuries account for 6.7, 7.2, and 9.0% of admissions for traumatic brain injury, traumatic intracranial hemorrhage, and severe traumatic brain injury respectively. These estimates can be improved if more studies are conducted and used across U.S. states as well." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving allopregnanolone?

"The current study failed to uncover any previous clinical trials involving ALLOP. Thus, it is likely that ALLOP is currently the only currently active pharmaceutical agent investigated in the U.S. for the treatment of SIDS." - Anonymous Online Contributor

Unverified Answer

How does allopregnanolone work?

"It is likely that allopregnanolone inhibits norepinephrine activity not only in the substantia noradrena but also in the locus ceruleus, thereby decreasing the response of brainstem noradrenergic neurons to norepinephrine, causing drowsiness. Furthermore, the fact that allopregnanolone also blocks α2-receptor-induced hypertonia and alpha-tocopherol- and N-acetylaspartylglutamate-induced hyperexcitability suggests that at least some of the clinical effects of this steroid are mediated by α2-receptor blockade." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating brain injuries?

"It seems that some of the recent advances have not advanced current thinking. Despite improvements in surgical technique and understanding of brain injuries, the optimal therapies are unknown. Further steps must be taken to better understand the processes that occur in the brain and to find a cure for brain injuries." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in allopregnanolone for therapeutic use?

"Allopregnanolone is a drug which has been shown to improve the recovery of neurons and reduce apoptosis after injury. In a recent study, allopregnanolone is a potential treatment for those who have suffered a traumatic brain injury and suffer amnesia due to anoxic brain damage. The drug has shown to be beneficial in patients suffering from brain damage caused by the accident, but the exact dosage needed to be administered is yet to be decided as a part of a human clinical trial. The drug is now being administered to those who have suffered traumatic brain injury and have suffered amnesia due to anoxic brain damage." - Anonymous Online Contributor

Unverified Answer

Does brain injuries run in families?

"Families of children with one confirmed [brain injury](https://www.withpower.com/clinical-trials/brain-injury) have a higher risk of repeated injury, compared with sibling families without a brain injury and with sibling families of healthy children, suggesting that familial influences, rather than genetic factors, underlie brain injuries." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of brain injuries?

"Of all injuries, the fall accounted for 40% of all injuries. However, the age of the patient and the presence of significant illnesses can also contribute to the overall injury burden of all of the injuries we included, with falls, assaults, motor vehicle crashes, and gunshot wounds also contributing significantly." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Traumatic Brain Injury (TBI) by sharing your contact details with the study coordinator.